Easy@Home Adhesive Electrodes

GUDID 00810038630052

EASY HEALTHCARE CORPORATION

Interferential electrical stimulation system electrode

• Primary Device ID: 00810038630052
• NIH Device Record Key: c28f21fa-7004-43b2-94c3-c7763c71f68a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Adhesive Electrodes
• Version Model Number: ETP538
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038630052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132588

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-11
• Device Publish Date: 2020-02-03

On-Brand Devices [Easy@Home Adhesive Electrodes]

• 00850253007178: ETP538
• 00850253007161: ETP505
• 00810038630052: ETP538
• 00810038630038: ETP505